Effect of testosterone therapy on outcomes after prostate surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the impact of testosterone replacement therapy (TRT) on functional and oncological outcomes in men with testosterone deficiency who are undergoing radical prostatectomy for prostate cancer. The study is a phase 3, randomized, placebo-controlled trial that will assess the efficacy and safety of TRT in improving sexual function and quality of life post-surgery. Participants will be screened for testosterone levels before and after the surgery to determine eligibility and monitor outcomes. The trial aims to provide insights into how TRT can mitigate the negative effects of both testosterone deficiency and prostate surgery.

Why it matters

Who can join: the full rules

Inclusion criteria

1. Men aged 18 years or older
2. Histologically confirmed prostate cancer
3. Radical prostatectomy performed as primary treatment
4. At least one-sided nerve-sparing procedure performed
5. Non-metastatic disease (cN0M0) based on the use of nomograms or imaging
6. Undetectable PSA level (\<0.1 µg/l or unmeasurable according to local protocol) within six weeks following RP
7. A preoperative minimal sexual function, defined as a score of 40 points or more (out of 100) for the EPIC-26 sexual function domain
8. Testosterone deficiency, defined as total testosterone \<8 nmol/L, or total testosterone between 8-12 nmol/L with free testosterone \<225 pmol/L, measured on two separate occasions, with normal or elevated luteinising hormone (LH)

Exclusion criteria

1. Prior prostate cancer treatment, including but not limited to anti-hormonal therapy, radiotherapy, or brachytherapy (active surveillance allowed)
2. Previous use of testosterone therapy for any reason
3. Pathological stage pT3b or pT4 in the RP specimen
4. Positive surgical margin(s) with ISUP grade 4 or 5 in the RP specimen
5. Presence of metastatic lymph nodes if pelvic lymph node dissection was performed
6. History of male breast cancer or liver tumour
7. Uncontrolled hypertension
8. General contraindications for TRT
9. Allergy for components in TRT agent or placebo
10. Use of vitamin K antagonists
11. Body mass index (BMI) \>30 kg/m²

Where it's running

• Amsterdam UMC location VUmc
  Amsterdam, Netherlands Recruiting
• Netherlands Cancer Institute
  Amsterdam, Netherlands Recruiting
• Rijnstate
  Arnhem, Netherlands Recruiting
• Catharina Hospital
  Eindhoven, Netherlands Recruiting
• Treant
  Emmen, Netherlands Recruiting
• Zuyderland
  Heerlen, Netherlands Recruiting

Study contacts

• Principal investigator: Diederik Somford, MD, PhD — Canisius-Wilhelmina Hospital
• Study coordinator: Joost van Drumpt, MSc
• Email: enforce@cwz.nl
• Phone: +31243658190

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.